Yesintek Biosimilar Shows Comparable Efficacy, Lower Immunogenicity Than Stelara, Says Elena Wolff-Holz, MD

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200 (Yesintek; ustekinumab-kfce), for psoriasis treatment, a biosimilar referencing Stelara (ustekinumab). She highlighted the comparable efficacy and safety with reference Stelara, including positive switching data.

Wolff-Holz believes biosimilars will increase patient access through reduced costs and suggests that reference product manufacturers should focus on innovative drug development. She noted that Yesintek has shown to be less immunogenic than the reference product, potentially offering an additional benefit to patients.

This transcript was lightly edited for clarity; captions were auto-generated.

Transcript

With the recent launch of three ustekinumab biosimilars in the US market, how do you see BMAb-1200 fitting into this rapidly evolving landscape?

I think the real comparison is really the biosimilars vs the reference medicine product, Stelara. Coming back to what biosimilars are, these are absolutely high quality products, highly regulated products, and the primary analysis really are at the quality level.

Comparative analytical studies are required, many more than you would have for new drug application and you have to look for physical chemical analysis, for biological functional comparability on very, very solid ground and then you go on with the PK study or with another trial. Actually, the onus, really, of the proof is in this initial quality comparison that really, truly, this is the same biologic drug, and this rigidity with which you have to prove the amino acid sequence is the same, the higher order structures are the same, the glycosylation pattern must be within very strict comparability model. All of this must be done by all biosimilar contestants, and you can only get approved if you have these if you have proven that this comparability exists.

One biosimilar vs another, I think here the features would be how the drug is given, so whether you have it in a PFS or other devices, things like that. Otherwise, it's really the same, and it's rather the question, do you still need the reference medicinal product on the market? That's really the question. I mean, they've been around for 10 years or even more, through patent prolongation. I really think their job should be to think of new drugs, innovative drugs. That is their primary capability, that should be their challenge.

I think they should leave the biosimilars alone. Once they're on the market, I think, from my point of view, the reference medicinal product is superfluous.

What are your thoughts on the impact that these biosimilars will have on patient access and the overall cost of psoriasis treatment?

I think BMAb-1200 or Yesintek on the market is just a wonderful addition to ustekinumab antibodies. I think the good news is it is less immunogenic than the reference medicine product. That is something that you observe, typically, not so much because of the product as such, that is the substance, the actual drug substance, but rather the fluid, the excipients that constitute the other part that makes up the medicinal product. This is something I would say that is quite, quite beneficial.

I think obviously the biggest advantage is reduced price, affordability is a big thing. Bringing down the costs considerably, and by doing that, increases the access patient access, it’s something that we've seen with many biosimilars.

There are many studies right now, the IQVIA report has nicely studied this, that this does happen, and it's really important, because ultimately, it improves health care. This would serve both sides and free up the space for more expensive, innovative drugs, but on the other hand, you would have then less expensive biosimilar products. This is something where I would think, Yesintek is a fantastic candidate.